Streetbeat News

Regulatory

GRI

GRI Bio has presented preclinical data indicating that oral administration of GRI-0803 inhibited lupus nephritis and significantly improved overall survival in animal models. The company expects to commence Phase 1a/b SLE study in 1H 2024 with topline results expected 2H 2024.

Portfolio Pulse from Benzinga Newsdesk

August 07, 2023 | 12:37 pm

GFGD

The Growth for Good Acquisition Corporation (NASDAQ:GFGD) has announced that its Registration Statement on Form S-4 for the business combination with Zero Nox Inc., a provider of sustainable, off-highway vehicle electrification, has been approved by the SEC. The business combination has been unanimously approved by the boards of both companies. Upon closing, the combined company will be named Zero Nox Inc. and will be listed on the NASDAQ under the ticker symbol 'ZNOX'. An extraordinary general meeting of shareholders is scheduled for August 23, 2023.

Portfolio Pulse from Happy Mohamed

August 07, 2023 | 12:35 pm

DYAI

Dyadic International, Inc. has announced the results from third-party analytical testing of the company's animal-free recombinant serum albumin. The results are expected to have a significant impact on the company's future operations.

Portfolio Pulse from Benzinga Newsdesk

August 07, 2023 | 12:35 pm

SAGE

Sage Therapeutics has received a Complete Response Letter from the FDA regarding its New Drug Application for zuranolone, a treatment for adults with major depressive disorder. This has led to a decrease in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

August 07, 2023 | 12:35 pm

RYTM

Rhythm Pharmaceuticals (NASDAQ:RYTM) has received pre-marketing early access authorization AP1 for its drug setmelanotide in France. The drug is intended for patients with hypothalamic obesity, a rare form of obesity caused by damage to the hypothalamic region of the brain. The AP1 allows for early access to innovative therapies prior to European regulatory approval. The drug has been available through a similar program for patients with Bardet-Biedl syndrome since July 2022.

Portfolio Pulse from Happy Mohamed

August 07, 2023 | 12:34 pm

IMNN

IMUNON, Inc. (NASDAQ:IMNN) has announced the availability of a manuscript on bioRxiv detailing the strong immunogenicity and protection offered by its PlaCCine DNA-based vaccines. The study used IMUNON's proprietary formulation against the spike proteins from two SARS-CoV-2 variants. The data shows that the vaccine is stable for up to one year at 4°C, induces spike-specific neutralizing antibodies and cytotoxic T cells, and can suppress viral replication. The company plans to commence a human clinical trial with PlaCCine in SARS-CoV-2 during the first quarter of 2024.

Portfolio Pulse from Happy Mohamed

August 07, 2023 | 12:33 pm

VTGN

Vistagen (NASDAQ:VTGN) has announced positive top-line results from its Phase 3 PALISADE-2 trial of fasedienol nasal spray for social anxiety disorder. The trial met its primary and secondary endpoints, demonstrating a statistically significant reduction in patient-reported distress and proportion of responders compared to placebo. Fasedienol was well-tolerated and demonstrated a favorable safety profile. The results highlight the potential for fasedienol to transform treatment for over 25 million people living with social anxiety in the U.S.

Portfolio Pulse from Happy Mohamed

August 07, 2023 | 12:31 pm

TRIB

Trinity Biotech has received 510(k) clearance from the FDA for the Premier Resolution System. This approval allows the company to market and sell the product in the United States.

Portfolio Pulse from Benzinga Newsdesk

August 07, 2023 | 12:01 pm

BTCUSD

ETHUSD

Veteran trader Peter Brandt predicts that 99.8% of altcoins will become worthless, similar to the fate of HEX coin. This follows a lawsuit by the SEC against Richard Schueler, alias Richard Heart, who is associated with HEX, PulseChain, and PulseX. The SEC alleges that Schueler conducted three unregistered securities offerings since 2019, raising over $1 billion. Schueler is accused of defrauding investors by misusing their funds for personal gain.

Portfolio Pulse from Mehab Qureshi

August 07, 2023 | 11:59 am

MRKR

Marker Therapeutics has announced non-clinical data for its lead multi-tumor-associated antigen (multiTAA)-specific T cell product candidate, MT-401, in an off-the-shelf setting. The company also provided an update on the clinical readiness for the off-the-shelf program.

Portfolio Pulse from Benzinga Newsdesk

August 07, 2023 | 11:36 am